NCT06636253

Brief Summary

Psychological stress is a frequent human affection and has a considerable impact on modern society, and tertiary-level students often report increased stress levels as the semester progresses. While many questionnaires assess psychological stress, they do not capture objective data. Much research has shown that electroencephalography (EEG) can capture objective markers of stress, and recent studies have shown that EEG can even classify stress levels. This study aims to assess the feasibility of using EEG to objectively assess stress over the course of a semester of work in chiropractic students engaged in a Masters level course in Scotland.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

September 12, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

Electroencephalogramstress

Outcome Measures

Primary Outcomes (5)

  • Feasibility recruitment rates

    recruitment rates - how many people were recruited ove rthe study time period

    0, 6, 12 weeks

  • Feasibility - retention

    Participant retention - how many participants completed the full study

    0, 6, 12 weeks

  • Feasibility - queries

    queries from participants - how many question did participants ask and were they answerable

    12 weeks

  • Feasibility - ease

    Ease of data collection - was the data collection procedure manageable for the investigator

    12 weeks

  • Feasibility - Adverse

    Adverse events - were any adverse events either minor or significant, recorded at any time throughout the trial

    12 weeks

Secondary Outcomes (3)

  • Electroencephalogram recordings

    12 weeks

  • Electroencephalogram recordings

    12 weeks

  • Electroencephalogram recordings

    12 weeks

Other Outcomes (1)

  • Depression, Anxiety, and Stress Scale - 21 (DASS-21)

    12 weeks

Study Arms (1)

SCC students

Healthy adults attending and actively enrolled in the Scotland College of Chiropractic's degree program and who were without health issues or mental disorders.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Scottish chiropractic college students

You may qualify if:

  • Healthy Scottish chiropractic students with no prior diagnosed mental disorder and who are capable of understanding the study procedure.

You may not qualify if:

  • A pre-diagnosed mental health disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scotland College of Chiropractic

Edinburgh, EH4 1HG, United Kingdom

RECRUITING

Study Officials

  • Alice Cade, BSc, BSc(chiro), MHSc, PhD

    Scotland College of Chiropractic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Cade, BSc, BSc(chiro), MHSc, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer and research fellow

Study Record Dates

First Submitted

September 12, 2024

First Posted

October 10, 2024

Study Start

October 15, 2024

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Upon reasonable request, anonymised post-process eeg data will be made available

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
01/10/2024 for up to two years (01/10/2026)
Access Criteria
Other researchers Via emailing the chief investigator

Locations